chimeric antigen receptor t-cell (car-t) cells in patients with r/r t-lbl

Conditions: T Cell Lymphoblastic Lymphoma

Summary: this is a single center, single arm, open-lable phase i study to determine the safety and efficacy of t cells expressing cd7 chimeric antigen receptors (referred to as "bt-007 car-t cells") in patients with relapsed or refractory acute t cell lymphoblastic lymphoma (r/r t-lbl).

primary objective: to investigate the safety and efficacy of cd7 car-t cells in the treatment of patients with relapsed or refractory acute t cell lymphoblastic lymphoma (r/r t-lbl). secondary objective: to assess the patient's quality of life after receiving the treatment.

Eligibility criteria:
inclusion criteria: 1. patients with cd7 positive t-cell lymphoma confirmed by histology; 2. relapsed refractory patients who received at least one line of systemic chemotherapy in the past; 3. at least one measurable target lesion; 4. age: 18-70 years old (including 18 and 70 years old); 5. the expected survival period is more than 3 months; 6. eastern cooperative oncology group (ecog) score 0-1; 7. important organ functions met: left ventricular ejection fraction≥50% according to cardiac ultrasound; serum cr≤1.25 times the upper limit of normal range (uln) or endogenous creatinine clearance≥45ml/min (cockcroft gault formula); alt and ast≤3 times uln, tbil≤1.5 times uln; 8. blood routine: hemoglobin (hgb)≥80g/l, neutrophil count (anc)≥1×10\^9/l, platelet plt≥50×10\^9/l； 9. coagulation function: international standardized ratio (inr)≤1.5 times uln; activated partial thromboplastin time (aptt)≤1.5 times uln (unless the subject is receiving anticoagulant treatment, and prothrombin time (pt)/inr and aptt are within the expected range of anticoagulant treatment at the time of screening); 10. the pregnancy test of women of childbearing age must be negative; both male and female patients need to agree to use effective contraceptive measures during the treatment period and within the following 1 year; 11. participate in this test voluntarily and sign the informed consent. exclusion criteria: 1. used immunosuppressive agents or therapeutic doses of corticosteroids (defined as prednisone\>20mg or equivalent dose) within one week before blood collection, or used drugs that stimulate bone marrow hematopoiesis, such as human granulocyte colony stimulating factor (g-csf); but physiological substitution, topical or inhaled steroids are permitted; 2. uncontrolled systemic active fungi, bacteria, viruses or other infections; 3. active hepatitis b (hbv dna\>500iu/ml), hepatitis c (hcv rna positive) or human immunodeficiency virus (hiv) antibody positive; 4. central nervous system invasion, or central nervous system disease history, such as epilepsy, cerebrovascular disease, etc; 5. pregnant or lactating women, or patients do not agree to use effective contraceptives during treatment and within the following 1 year; 6. receiving allogeneic hematopoietic stem cell transplantation or organ transplantation; 7. previous history of other malignant tumors. patients with cured skin basal or squamous cell carcinoma and cervical carcinoma in situ at any time before the study were not included; patients with other tumors not listed above, but which have been cured by surgery but not by other further treatment measures, and disease-free survival≥5 years, can be included in the study; 8. patients with primary immunodeficiency or autoimmune diseases, but asymptomatic hypothyroidism, or well controlled type i diabetes can participate in this study; 9. patients who participated in other clinical trials within 4 weeks before blood collection; 10. the investigator considers that there are other factors that are not suitable for inclusion or affect the subjects to participate in or complete the study.